System and method for assessing urinary function

ABSTRACT

A portable, self-contained medical diagnostic system is provided for assessing urinary function. The system includes a control device including a processor, a pump device, and a pressure sensor, and a test module removably coupled to the control device, and further including a pressure interface and a tubing assembly defining a first fluid conduit between a first fluid inlet and a first fluid outlet. The pump device is coupled to the first fluid conduit for pumping fluid therethrough. The system also includes an insert member having a first channel therethrough and coupled to the first fluid outlet so that fluid flowing through the first fluid conduit may flow through the first channel. The insert member is dimensioned for insertion into a patient&#39;s bladder through the urethral canal. When so inserted, the pressure interface transmits bladder pressure information to the pressure sensor.

CROSS REFERENCE TO RELATED APPLICATIONS

The present invention claims the benefit of earlier filed U.S.provisional patent applications, Ser. Nos. 60/302,069, filed on Jun. 29,2001 and 60/372,579, filed on Apr. 12, 2002, which are both incorporatedby reference in their entirety herein.

FIELD OF THE INVENTION

The present invention relates generally to a system and a method forassessing urinary function. More particularly, the system and method isused for testing the integrity of the urinary system for diagnosticpurposes and for use with therapies to correct urinary incontinence.

BACKGROUND OF THE INVENTION

Women account for more than 11 million of incontinence cases. Moreover,a majority of women with incontinence suffer from stress urinaryincontinence (SUI). Women with SUI involuntarily lose urine duringnormal daily activities and movements, such as laughing, coughing,sneezing and regular exercise.

SUI may be caused by a functional defect of the tissue or ligamentsconnecting the vaginal wall with the pelvic muscles and pubic bone.Common causes include repetitive straining of the pelvic muscles,childbirth, loss of pelvic muscle tone and estrogen loss. Such a defectresults in an improperly functioning urethra. Unlike other types ofincontinence, SUI is not a problem of the bladder.

Normally, the urethra, when properly supported by strong pelvic floormuscles and healthy connective tissue, maintains a tight seal to preventinvoluntary loss of urine. When a woman suffers from the most commonform of SUI, however, weakened muscle and pelvic tissues are unable toadequately support the urethra in its correct position. As a result,during normal movements when pressure is exerted on the bladder from thediaphragm, the urethra cannot retain its seal, permitting urine toescape. Because SUI is both embarrassing and unpredictable, many womenwith SUI avoid an active lifestyle, shying away from social situations.

SUI is categorized into three types. Type I and Type II are directed tourethral hypermobility. Type III is directed to intrinsic sphincterdeficiency (ISD). Diagnosis of ISD requires urodynamic evaluation.Urodynamic evaluation involves complex and invasive equipment and oftenrequires referral to a specialist trained in urodynamic evaluation.

Existing diagnostic systems all require a catheter be passedtrans-urethraly to measure pressure, such as Leak Point Pressure(LPP)—or Urethral Pressure Profile (UPP). An exemplary system isdisclosed in publication (WO 0023127). Detection of LPP requires that apressure sensor and catheter be passed trans-urethrally. The bladder isfilled, and pressure is recorded. Fluid leakage from the urethralopening (meatus) corresponds to the maximum pressure the urethralsphincter can resist, or LPP. During the UPP measurement procedure apressure sensor tipped catheter is placed trans-urethral into thebladder and then withdrawn at a constant velocity. The pressure profilealong the urethra, from bladder neck to meatus is recorded.

Other parameters may also be measured, such as abdominal pressure andurinary flow. A cystometrogram (CMG) is a pressure study thatsimultaneously measures intra-abdominal, total bladder, and truedetrusor pressures. Uroflometry measures urine flow rate visually,electronically, or via a disposable system. Video Urodynamic Systemsalso exist that simultaneously measure parameters, as described above,with radiographic visualization of the lower urinary-tract.

Existing urodynamic evaluation systems are complex, expensive, andrequire extensive training. Furthermore, existing urodynamic systemsoften require at least 30 minutes to complete a test. This exceeds thetime available for most standard physician office visits and results inreferral to a specialist. No urodynamic system exists that can quicklyand inexpensively record useful urodynamic measures, without passing acatheter or instrument trans-urethraly.

There remains a need for an improved system and method for assessingurinary function.

SUMMARY OF THE INVENTION

A portable, self-contained medical diagnostic system for assessingurinary function is provided including a control device including aprocessor, a pump device, and a pressure sensor, and a test moduleremovably coupled to the control device. The test module includes apressure interface and a tubing assembly defining a first fluid conduitbetween a first fluid inlet and a first fluid outlet, wherein the pumpdevice is coupled with the first fluid conduit for pumping fluidtherethrough. The system further includes an insert member having afirst channel therethrough and coupled to the first fluid outlet so thatfluid flowing through the first fluid conduit may flow through the firstchannel, the insert member being dimensioned for insertion into apatient's bladder through the patient's urethral canal, such that, whenthe insert member is inserted into the patient's bladder, the pressureinterface is in fluid communication with the bladder such that apressure at the pressure interface substantially corresponds to apressure within the bladder. The pressure interface is furtherpositioned relative to the pressure sensor so as to transmit bladderpressure information thereto.

Also provided is a medical diagnostic system including a control deviceincluding a processor and pump device electrically coupled to andcontrolled by the processor, a test module removably coupled to thecontrol device and including a tubing assembly having a first fluidinlet, a first fluid outlet, and a first fluid conduit extendingtherebetween, and an insert member coupled to the tubing assembly fluidoutlet and having a channel therethrough in fluid communication with thefirst fluid conduit. The insert member is dimensioned for insertion intoa patient's bladder through the patient's urethral canal. The systemalso includes a pressure detection system for detecting pressurecorrelating to a pressure within the bladder. The pump device is coupledto the first fluid conduit to thereby be capable of pumping fluidthrough the first fluid conduit and insert member channel and into thebladder, and the pressure detection system is capable of detecting thepressure within the bladder as fluid is pumped therein.

A method is also provided for assessing urinary function including thesteps of removably coupling a test module to a control device to form aportable, self-contained diagnostic system, wherein the control deviceincludes a processor, a pump device and a pressure sensor, and thetesting module includes a fluid tubing assembly having a first fluidinlet, a first fluid outlet and a first fluid conduit extendingtherebetween. The method further includes the steps of coupling to thefirst fluid outlet an insert member having a channel therethrough influid communication with the first fluid conduit, coupling the firstfluid inlet to a fluid source, inserting the insert member into apatient's bladder through the patient's urethral canal, activating thepump device to thereby infuse fluid from the fluid source through thefirst fluid conduit and insert member channel and into the bladder; andmeasuring pressure within the bladder as fluid is infused therein.

The present invention also provides a self-contained medical diagnosticsystem for assessing urinary function including a control deviceincluding a processor, a pump device electrically coupled to andcontrolled by the processor, and a first pressure sensor, and a testingmodule removably coupled to the control device. The testing modulefurther includes a first fluid conduit extending between a first fluidinlet and a first fluid outlet, and a second conduit having a first openend and a first pressure interface in fluid communication therewith. Thesystem also includes a first insert member having first and secondchannels therethrough, the first channel being in fluid communicationwith the first fluid conduit and the second channel being incommunication with the second conduit. The insert member is dimensionedfor insertion into a patient's bladder through the patient's urethralcanal. The pump device is coupled to the first fluid conduit forinfusing fluid through the first fluid conduit, the first insert memberchannel and into the bladder, and the first pressure interface and firstpressure sensor are positioned relative to one another so that the firstpressure interface transmits pressure information to the first pressuresensor.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 is a perspective view of a one embodiment of a portable medicalsystem according to the present invention;

FIG. 1 a is a front view of one embodiment of a portable medical systemaccording to the present invention;

FIG. 2 is a front perspective view of a control device according to thepresent invention;

FIG. 3 is a rear perspective view of the control device of FIG. 2;

FIG. 4 is a front elevational view of a control device in accordancewith the present invention attached to a pole;

FIG. 4 a is an exploded perspective view of one embodiment of a poleattachment mechanism;

FIG. 4 b is a rear perspective view of the pole attachment mechanism ofFIG. 4 a;

FIG. 4 c is a rear view of the pole attachment mechanism of FIG. 4 awhen not secured to a pole;

FIG. 4 d is a rear view of the pole attachment mechanism of FIG. 4 awhen secured to a pole;

FIG. 5 is an exploded perspective view illustrating interaction of acontrol device identification mechanism and module identificationcomponents;

FIG. 5 a is a schematic cross-sectional view taken across line 5 a—5 aof FIG. 5 prior to engagement of the control device with the testmodule;

FIG. 5 b is a schematic cross-sectional view similar to FIG. 5 a showingengagement of the control device with the test module;

FIG. 6 is a front perspective view of a module according to the presentinvention;

FIG. 7 is a schematic illustration of one embodiment of control deviceelectronics assembly;

FIGS. 8 a–8 i are flow diagrams illustrating operation of control devicesoftware and graphical user interface components;

FIG. 9 is an alternate embodiment of a medical system according to thepresent disclosure;—

FIG. 10 is a schematic representation of a portable medical systemincluding an SUI module;

FIG. 10 a is a partial cross-sectional view of one embodiment of aportable medical system including an SUI module;

FIG. 10 b is an enlarged view illustrating a pressure transducer andfilter according to one embodiment of the present invention;

FIG. 11 a is a side elevational view and partial cross-section of oneembodiment of a hand actuator in an assembled configuration;

FIG. 11 b is a side elevational view and partial cross-section of thehand actuator of FIG. 11 a in an unassembled configuration;

FIG. 11 c is a side elevational view and partial cross-section of thehand actuator of FIG. 11 a in an operational mode;

FIG. 11 d is an alternative embodiment of a hand actuator according tothe present invention;

FIG. 12 is an enlarged perspective view of one embodiment of a meatusplug device;

FIG. 13 is a schematic view of illustrating one embodiment of aurodynamic system in relation to a female urinary/reproductive system;

FIG. 14 is a schematic view illustrating internal components of oneembodiment of a system including a SCMG module;

FIGS. 15–16 are schematic views of the system of FIG. 14 in relation toa female urinary/reproductive system;

FIG. 17 is a schematic view illustrating one internal components of oneembodiment of a system including a CCMG module;

FIGS. 18–19 are schematic views of the system of FIG. 17 in relation toa female urinary/reproductive system;

FIG. 20 is a flow diagram illustrating steps for using the system ofFIG. 10;

FIG. 21 is a flow diagram illustrating steps for using the system ofFIG. 14;

FIG. 22 is a flow diagram illustrating steps for using the system ofFIG. 17;

FIG. 23 is a perspective view of one embodiment of an input pendantaccording to the present invention;

FIG. 24 is a schematic view illustrating internal components of oneembodiment of a system including a Uroflowmetry module;

FIG. 25 is a schematic view illustrating use of the system of FIG. 24;

FIG. 26 is a perspective view of one embodiment of a vaginal speculumassembly in accordance the present invention;

FIG. 27 is an exploded perspective view of the vaginal speculum assemblyof FIG. 26;

FIG. 28 is a schematic view of one embodiment of a urodynamic system andspeculum assembly in relation to the female urinary/reproductive system;and

FIG. 29 is an exploded perspective view of a battery charger module thatcan be used in conjunction with the control device.

DETAILED DESCRIPTION OF THE EMBODIMENTS

FIGS. 1 through 26 illustrate generally various systems and methods forassessing urinary function and/or components of such systems andmethods. Although the systems and methods disclosed herein are describedin detail in relation to the female urinary system, it is to beunderstood that the present invention can readily be adapted for use inassessing male urinary function as well. Further, those skilled in theart will recognize that inventive principles, apparatus and methodsdisclosed herein may also have application to assessing function inother areas, such as coronary function or pulmonary function. Thepresent invention is to be limited only by the claims set forth herein.

Referring now to FIGS. 1 and 2, one embodiment of a portable medicalsystem 100 is illustrated having particular application for assessingurinary function. The system 100 includes a control device 102 thatcontrols operation of the system, at least one module 104 that can beremovably coupled to the control device, at least one input device, suchas the illustrated input pendant 106 and/or keypad 108, and at least oneoutput device, such as the illustrated display screen 110. As will bedescribed in more detail below, the control device 102 is designed to beremovably coupled to any one of a plurality of testing modules 104 atany given time. As each module is uniquely suited to support a differenttype of diagnostic test or medical procedure, the resulting diagnosticsystem is not only readily portable, but is also extremely versatile inthat the single control device, in conjunction with a plurality of smalltest modules, is capable of performing an array of diagnostic tests orother procedures. The system has particular application useful forassessing urinary function in that it provides a portable, modularsystem in contrast to the non-portable, expensive, and cumbersomeequipment that is currently used for assessing urinary function. Inaddition, as will also be described in greater detail below, the presentinvention can perform tests quicker, and in a manner that is lessuncomfortable and less invasive for a patient.

The control device 102 includes a housing 112 for housing variouscomponents, including one or more batteries 114, an electronics assembly116, a pump device 118 including a motor, and various other circuitry.Batteries supply power to the control device 102, and are containedwithin a battery compartment 120 that is accessible by removing thebattery cover 122 that forms part of the housing 112. The control devicefurther includes an input keypad 108 for allowing a user to input data(such as patient name or other identifier, numeric identifiers, patienthistory, date etc.) and an input pendant 106 including one or moreswitches 124 that allow user input of additional information (i.e.,event input based on patient feedback), and an activation switch 126 forturning the device on and off. The pump device 118 and at least onepressure transducer 128 are also contained within the housing. The pumpdevice is electrically coupled to the battery and the electronicsassembly, and the pressure transducer is electrically coupled to theelectronics assembly. The control device 102 may also include a polemounting mechanism 400 for mounting the control device on a pole such asthe pole of an IV solution caddy 402 including a hook 404. Oneembodiment of a pole mounting mechanism is illustrated in FIGS. 4 a and4 b. The device may also include an interface 130 including appropriateelectrical pinouts to enable the control device to communicate forpurposes of battery recharging or printing of patient test data.

As indicated above, any one of a plurality of modules 104, such asdiagnostic test modules, can be removably coupled to the control device102, and the control device is designed to uniquely identify theattached module, and perform routines specific to that module. Thus, thecontrol device includes a module detection mechanism 500 capable ofidentifying the attached module that is electrically coupled to theelectronics assembly (see FIG. 5). This module detection mechanismincludes one or more identification probes 502 that project from theinterface side 132 of the control device and are electrically coupled tothe electronics assembly. The modules 104 may include one or moreapertures in the module housing 506 that are designed to receive thereinthe identification probes when the module is removably coupled to thecontrol device. When so coupled, the identification probes will bridgeone or more module identification elements or components 504, such asresistors, capacitors, fuses or other suitable electronic components,present within the module. The identification probes are electricallycoupled to the electronics assembly 116 (described more fully below),which determines a value, such as resistance, associated with the moduleidentification element(s) that they bridge. Each module is designed tohave a value so that identification of this value by the electronicscontrol assembly enables the control device to uniquely identify theattached module. In a preferred embodiment, the control device mayinclude one or more sets of identification probes 502 at differentlocations, and different modules have a module identification components504 at different locations. The location, as detected by the controldevice, identifies the attached module. In yet another embodiment, themodule identification component(s) may be coupled to an exterior side ofthe module housing so that apertures in the module housing are notrequired.

The module further includes at least one coupling element 600 forremovably coupling the module to the control unit (see FIG. 6). In theillustrated embodiment, the module includes four coupling elementsplaced toward the ends of each of the front and rear faces 602, 604 ofthe test module. Each coupling element contains a tab element 606 thatengages a corresponding ridge 607 (best seen in FIG. 5) on an interiorsurface of the control device when the module is removably coupled tothe control device. To couple the module to the control unit, thecoupling elements are depressed slightly in the direction indicated bythe arrow in FIG. 6.

The module is then aligned with the control device as shown in FIG. 1,and the coupling elements released to allow engagement with thecorresponding ridges described above. The module can subsequently beremoved from the control unit by once again depressing the couplingelements and removing the module from the control device.

Finally, the module housing 506 includes first 608 and possibly second610 ports therein as shown in FIG. 6. Each of the first and second portsare configured so as to define a recess capable of receiving a controldevice pressure sensor, such as a pressure transducer, therein when themodule is coupled to the control device. For example, a first controldevice pressure transducer 128 is received within the first port recess608 and comes in physical contact with a pressure interface 1024 (seeFIG. 10) so that pressure changes at the pressure interface can betransmitted to and detected by pressure transducer 128 and converted toelectrical signals that are sent to the electronics assembly forinterpretation. Similarly, the second port 610 also defines a recesscapable of receiving therein a second control device pressure transducer1030. The first and second ports are further configured to form anairtight seal with the control device when coupled thereto, preferablyby incorporating sealing elements such as gaskets or the like.Individual modules and their operation in conjunction with the controldevice will be described in greater detail below.

As indicated above, contained within the housing 112 of the controldevice 102 is an electronics assembly 116 (see FIG. 7) that is designedto control operation of the pump device 118, to acquire and format datafrom the pressure transducer(s), to drive a display 110 and/or otheroutput device, and to accept and interpret input data, such as fromswitches 108, 126, and/or 124. The electronics assembly 116 consists ofan integrated circuit board 702, hardware interfaces to the pump device708, pressure transducer 706, 707, display 709 and switches 703, 704 and705; and a microprocessor 710. The microprocessor 710 serves as the maincontroller for the diagnostic system and is supported by the customintegrated circuit 702 and powered by the batteries. Also included areinterface connection elements including an electronic moduleidentification connection 712 to the electronic detection mechanism 500,and electronic connections 714 that enable downloading of data to aprinter or other external device.

The microprocessor 710 is programmed with a custom program file. In theillustrated embodiment, this software has multiple functions. First isthe acquisition of input from the operator. This input data is capturedfrom the input keypad 108, and/or switches 124, 126, pressuretransducer(s) or other input device, depending upon which test module isin use. The software also controls operation of the pump device 118.Input data is interpreted and appropriate signals are sent to the pumpdevice motor via the integrated circuit board 702. Yet another functionis to acquire and condition data from the pressure transducer(s). Thisdata is then sent in the appropriate format to the display 110, alongwith applicable pump device data in the form of volume or timeinformation. Finally, as indicated above, the software receives inputfrom the module detection mechanism 500 and interprets this input todetermine which test module is coupled to the control device.

FIG. 8 a–8 i are flow diagrams illustrating operation of the diagnosticsystem software and features of the system graphical use interface for apreferred embodiment of the invention. When the system is powered on,the user is first presented with a welcome screen. While this screen isbeing displayed the system is undergoing a self-test routine 802 to testthe integrity of system hardware and software components. Uponcompletion of this routine, the user is provided with informationrelating to the amount of available system memory 804. Following thepressing of any key 806 on input device 108 by the user, the systemidentifies the attached module 808 as described above, and followingsuch identification, the processor executes a software subroutinespecific to the identified module. For each software subroutine,however, a main menu is displayed next, such as that indicated byreference numeral 810. In the illustrated embodiment, the main menuincludes six possible selections. “Utilities” enables the user to accessvarious system features, such as setting the date, time etc, oradjusting the brightness or contrast of the screen; “Quit” terminatesthe session; “Patients” enables the user to access any previously storeddata relating to other patients and tests already performed; “Prime”initiates the pump priming process; “Patient ID” enables the user toenter a patient identification number; and “Test” initiates a softwaresubroutine specific to the attached module to carry out the desired testprocedure. In the presently described embodiment, the software and userinterface associated with the “Prime,” “Utilities,” “Quit,” and “PatientID” selections are substantially the same for each software subroutine.The “Test” and “Patients” selections, however, are different for eachtest module. Each of these selections will be described in greaterdetail below.

As is illustrated in FIG. 8 a, the first time the main menu is displayedboth “Test” and “Prime” appear in a different color or shade from theother options, indicating that they are not currently available. This isto ensure that patient identification information is entered beforeproceeding with any priming or testing procedures. The user may selectthe “Patient ID” option by scrolling using the appropriate arrows on theinput keypad 108. Following this selection the Patient ID screensappears 820 (FIG. 8 b). In the illustrated embodiment, the patient IDconsists of a nine digit integer. To enter the patient ID, the userscrolls to a selected blank using the left and right arrows and/or leftand right arrows on the input keypad 108 (824) to select desirednumbers. Once the desired number is selected, the user presses ENTER;the selected number will then appear in the rightmost blank. Subsequentnumbers are selected as described above, and will appear in therightmost blank while previously selected numbers move to the left. Thisprocess is completed until all blanks are filled in. In one embodiment,there is a default value for each blank, such as 0, and the user mayproceed with testing by accepting the default patient ID numberconsisting of all 0's. Once complete patient identification informationis entered, the user selects the “Main Menu” option 832, which returnsto the main menu screen. At this point, however, the “Prime” optionbecome available 834 (and “Patient ID” is no longer available).

Before performing any test that requires fluid to be infused into thepatient, priming operations must be performed to ensure that the fluidinfusion lines (tubing) are filled with fluid and not air. Referring nowto FIG. 8 c, the user selects the “Prime” option 840 by using the arrowkeys to select the option, and then pressing the enter key. The Primescreen then appears. According to one embodiment, the Prime screenincludes two options as indicated at 842: “Prime” or “Main Menu.” Inanother embodiment, the Prime screen is particular to each module, andmay present only one option to initiate priming. Selecting the Primeoption causes the pump to start and run for a predetermined amount oftime, such as 20 seconds, and then automatically shuts off. The user isthen presented with a screen 846 at which the user can accept the primeas complete (MAIN), or choose to reprime (PRIME). When priming isaccepted as complete, the main menu once again appears, this time with“Test” as an option 848. In another embodiment, priming operations maybe specifically tailored for different test modules. For example, aswill be described in more detail below, the SUI test modules includes ahand actuator including an activation button 1118 or 1128. The systemmay be designed so that following display of the Prime screen, pumppriming operations can be initiated by depressing the activation button.

With priming complete, testing can begin. As indicated above, testingprocedures depend on the attached test module, and accordingly, thesoftware and graphical user interfaces relating to each test module willbe discussed in greater detail below in conjunction with the detaileddescription of each test module.

In an alternative embodiment of the invention illustrated in FIG. 9, thecontrol device 102 is electrically coupled to a laptop/standard computer900, and the microprocessor and associated software reside in thecomputer.

As indicated above, the diagnostic system described herein hasparticular application to urodynamics in that it enables clinicians todiagnose a plurality of urinary incontinence problems when used withspecifically designed testing modules (to be discussed hereinafter). Asa miniaturized urodynamic tool, the control device 102 in conjunctionwith modules 104 can measure urethral resistance pressure (URP), voidingflow (Uroflometry), and bladder dysfunction (Cystometrogram (CMG)). Aswill be described further below, URP is a new and unique approach tourodynamic measurement of stress incontinence that is less invasive fora patient, and faster than currently known and used diagnostic tests.Uroflometry is the study of micturation over time. CMG is the study ofbladder or detrusor instability. A major advantage of the diagnosticsystem disclosed herein is that it can achieve all of the diagnostictests described above with a portable unit that can be used in anyoffice exam room, removing the need for the reservation or scheduling ofa specialized urodynamic room, and the need for the complex equipmentcurrently required for such tests. The urodynamic system is easy to useand does not require advance training. Use of the disclosed system makestesting more comfortable for patients by enabling faster set up, shortertest time, and less invasive procedures.

In actual use, different modules can be removably coupled to the controldevice 102 to conduct these different urodynamic tests. Each moduleperforms a different and distinct test. These modules include, but arenot limited to, a stress urinary incontinence (SUI) module formeasurement of urethral resistance pressure (URP); a simple CMG modulefor measurement of bladder instability; a complex CMG module formeasurement of bladder instability; and a uroflometry module for thestudy of micturation over time. Modules may be suitably adapted toeither male or female incontinence diagnosis.

Before proceeding with a discussion of individual test modules, toassist the reader a brief overview of the female urinary system will bedescribed with reference to FIG. 13. The female urinary system 1300includes an elongated urethral canal 1302 having a urethral meatus(entrance) 1304 and having a substantially circular-shaped urethralsphincter muscle 1306 attached thereto, and a bladder cavity 1308surrounded by a detrusor muscle 1310. The detrusor muscle 1310 alsosurrounds and supports the urethral canal 1302. The bladder cavity 1308is in close proximity to the abdominal wall 1312, the pubis bone 1314,the pelvic floor 1316 (levator ani muscle), the vaginal canal 1318, theclitoris 1320, the uterus 1322 and the anal sphincter muscle 1324.

Individual testing modules will now be described in detail.

STRESS URINARY INCONTINENCE MODULE

FIGS. 10–13 illustrate one embodiment of a stress urinary incontinencetesting module (SUI) 1000 for diagnosing the involuntary loss of urineduring physical activities such as coughing, sneezing, laughing orlifting. The SUI testing module 1000 includes a SUI module housing 1002that can be removably coupled with the control device 102 as describedabove The module housing may be in the form of a plastic disposablecartridge. Within the module housing is a tubing assembly 1004 includinga fluid inlet 1006, a fluid outlet 1008, and a first fluid conduit 1010extending therebetween. Tubing loop 1012 forms part of the tubingassembly and is positioned so that, when the SUI testing module iscoupled to the control unit, the stator 1014 of the pump device 118 inthe control unit 102 cooperates physically with the tubing loop 1012 sothat the pump device operates as a peristaltic pump to pump fluidthrough the first fluid conduit 1010. To assist in this regard, a tubingguide 599 aids in positioning a portion of the tubing assembly so thatit will properly and effectively engage the peristaltic pump. Accordingto the illustrated embodiment, tubing guide 599 has a substantiallyU-shaped configuration, however, many other configurations are suitable,as the principles of operation of peristaltic pumps are well known inthe art. Tubing member 1050 also forms part of the first fluid conduit.The module housing 1002 also includes a pressure chamber 1016 fordampening pressure fluctuations that may be caused by operation of thepump device. The pressure chamber 1016 is in fluid communication withthe first fluid conduit 1010 via valve openings 1018 a–c of three-wayvalve member 1020. The pressure chamber is filled primarily with air,but varying amounts of fluid may also be present. Positioned at a distalend of pressure chamber 1016 is a filter component 1022 designed toisolate fluid from electronic elements of the system 100. In thisregard, filter 1022 may be a hydrophobic filter that allows air to passinto pressure interface 1024, but not liquid. When the testing module iscoupled to the control device 102, pressure interface 1024 is inphysical contact with pressure transducer 128 of the control device sothat pressure fluctuations within the pressure chamber 1016 and pressureinterface 1024 can be transmitted to and sensed by the pressuretransducer, and subsequently transmitted to the electronics assembly asindicated above. In this manner, the control device measures pressurewithin the first fluid conduit of the tubing assembly of the SUI testingmodule, which substantially corresponds to the pressure within theurethral canal as described more fully below.

The SUI testing module 1000 tubing assembly also includes a secondtubing member 1025 having a channel therethrough forming a second fluidconduit between a proximal end 1026 and a distal end 1028.

Referring now to FIGS. 11 a–c, the SUI testing module may also include ahand actuator 1100 having and insert device such as a meatus plug device1102 attached thereto. The meatus plug device 1102 (see FIG. 12)includes an attachment member 1104 at a proximal end 1106 coupled to aplug or insert element or member 1108 at a distal end 1110, and achannel 1112 extending therethrough allowing fluid flowing through thefirst fluid conduit to flow through the meatus plug device. The distalend 1114 of the plug element may also include one or more transverselyaligned apertures or openings 1116 therein approximately equally spacedapart from one another around the exterior surface of the distal end. Asthe outer diameter of the distal end at the location of the apertures isless than the diameter of the inner wall of the urethral canal at thatlocation (described more fully below), one or more of the apertures 1116can be used for assurance of fluid flow into the urethra during actualoperation.

In one embodiment, the hand actuator further includes a hand-sizedhousing or casing 1102 including therein an initiator element 1118(FIGS. 11 a–c) that is in fluid communication with tubing member 1025.Preferably, initiator element is an air bladder 1097 coupled to a distalend 1028 of the tubing member 1025. The proximal end 1026 of tubingmember 1025 coupled to a pressure interface 1026 a that is positioned sothat, when the SUI testing module is coupled to the control device,pressure within tubing member 1025 can be sensed by pressure transducer1030. As a closed system, pressure on the activation button 1118 can besensed at the pressure interface 1026 a by pressure transducer 1030, andinterpreted by control device 102 as a signal to initiate and/ordeactivate the test.

The hand actuator 1100 further includes a fluid conduit 1050 extendingbetween an outlet 1195 and an inlet 1194 that is coupled to (integrallyor otherwise) an external tubing conduit leading to a fluid source, suchas the first fluid conduit 1010 of the SUI test module. Alternatively,the hand actuator may be designed to include therein the fluid source.The fluid outlet 1195 is in fluid communication with the insert memberchannel of the meatus plug device. An activation device 1127 including atrigger 1128 extends through an opening 1118 a to an exterior of thecasing. The activation device 1127 is movable between a first restposition (shown) and a second activated position. In the first positionspring 1130 exerts force on coupling member 1132, causing it to pivotrelative to pivot element 953 and pinch the distal ends of at leasttubing member 1050 to prevent fluid flow therethrough. When in thesecond position, movement of the trigger causes the coupling member 1132to pivot to a point at which it no longer pinches tubing member 1050.Further, trigger 1128 may also compresses air bladder 1097 to initiatetesting as described above in connection with initiator element.

The plug element 1108 is configured so that, when inserted into theurethral meatus of a patient (see FIG. 13), it will substantially blockor prevent fluid flow out of the urethra, as well as into the urethraother than through the meatus plug device channel 1112. Further, wheninserted, the plug element is positioned distal of the urethralsphincter 1306 (toward the outside of the body) as shown in FIG. 13. Inthe embodiment shown in FIG. 12, the distal end or distal portion 1114of the plug element is substantially conical in shape, and decreases indiameter toward its distal end 1114. A proximal portion 1199 isconfigured to engage the inner wall of the urethral canal tosubstantially prevent fluid flow therebetween. Other shapes, however,are also possible so long as fluid flow into or out of the urethral issubstantially blocked (other than through the meatus plug devicechannel) and the plug element remains located distal of the urethralsphincter. The meatus plug device 1102 is made of a biocompatiblematerial, such as stainless steel or polypropylene. The meatus plugdevice may be disposable, but may also be made of a sterilizablematerial so that it can be reused.

The first fluid conduit 1010 of the tubing assembly also includes anelongated single lumen tubing member 1032 having a first end 1006 and asecond end 1034 and a fluid channel extending therethrough. A spikedevice 1036 is coupled to the first end 1006 of the single lumen tubingmember for attachment to a fluid bag 1038 (having a fluid 1010 therein)in a manner well known in the art. As described above, the meatus plugdevice and first fluid conduit are coupled to one another such thatfluid from the fluid source traveling through the first fluid conduitmay pass through the insert member (via the channel therein) and intothe urethral canal distal of the urethral sphincter. Further, as thefirst pressure interface 1024 is in fluid communication with the firstfluid conduit and ultimately the urethral canal, pressure at thepressure interface substantially corresponds to the pressure within theurethral canal distal of the urethral sphincter.

Use of the system 100 including a SUI testing module 1000 is as follows.First, the SUI testing module is removably coupled to the control device102 in the manner described above. The physical coupling causes theidentification probes 502 of the control unit to engage the moduleidentification element(s) 504 of the SUI testing module, enabling thecontrol device to identify the SUI testing module. The physical couplingalso brings pressure interface 1024 in physical contact with pressuretransducer 128 as described above so that pressure changes at thepressure interface can be detected by the pressure transducer andtransmitted to the electronics assembly for interpretation. The pressureinterface 1026 a at the proximal end of tubing member 1025 similarlycomes in contact with pressure transducer 1030 so that pressure withintubing member 1025 can also be detected. Finally, the tubing loop 1012is brought into physical contact with the pump device 118 so that thepump device can drive fluid through the first fluid conduit byperistaltic motion, as described above.

As shown in FIG. 20, once the SUI testing module 1000 is coupled to thecontrol device 102 (2010), the operator enters appropriate input datainto the keypad 108 or other input device (2015) for the SUI test(described in more detail below). This data is received and interpretedby the microprocessor 710 and applicable information is sent by themicroprocessor to the display 110. Priming operations are then performed(2020) to ensure that the first fluid conduit 1010 contains fluid. Atthis point, the microprocessor is ready to start the test routine.

The meatus plug 1102 is inserted into the meatus of the urethra (2025)and the test is started (2030) by pressing the activation button asdescribed above. This in turn sends instructions to the pump device viathe integrated circuit. The pump device then pumps fluid 1040 throughthe first fluid conduit 1010 and meatus plug device channel 1112 andinto the urethral canal distal of the urethral sphincter (2035). Asfluid pressure builds in the urethral canal 1302, pressure in thepressure chamber 1016 also builds. This pressure is transmitted throughthe filter component 1022 and pressure interface 1024 to the pressuretransducer 128, which receives the pressure data and transcribes it intoan electrical signal. The electrical signal from the pressure transduceris sent to the microprocessor 710 via the integrated circuit 702 whereit is acquired and conditioned. The information is then sent to thedisplay 110 via the integrated circuit. The microprocessor ends the testafter a specified amount of time, or upon receipt of input from the userby sending an “off” signal to the pump motor drive. Once the test hasbeen completed, the operator disengages the activation button 1118 (step2040) and removes the meatus plug element from the meatus 1304 (2045).

Referring once again to FIGS. 8 a–i, and in particular FIG. 8 d, whenthe “Test” option is selected the SUI test can be performed. The SUITest screen appears 860, and the user initiates the test by depressingthe trigger 1128 or movable shell 1126 (862) to allow fluid flow intothe urethral canal as described above. The motor is then activated andthe pump device pumps fluid into the urethral canal for a predeterminedperiod of time, preferably 15 to 20 seconds. During this time a graph(see 860) is continuously displayed illustrating measured pressure onthe vertical axis (preferably in cm of water) versus time on thehorizontal axis. As fluid is pumped into the urethral canal, pressurewithin the urethral canal distal of the sphincter continues to increaseuntil that point in time at which the urethral sphincter yields (open)under the force of the pressure within the urethral canal. At that pointthe pressure curve becomes substantially flat, as illustrated in FIG. 8d, since the sphincter is open and fluid is filling the bladder. Thevalue of the flat portion of the curve is considered the “urethralresistance pressure (URP),” and can be obtained from the displayedgraph. On completion of the test (after expiration of the predeterminedtime period the pump device stops), the graph remains, and the user ispreferably provided with an option to adjust the software generated URPvalue (860 a) before saving the test results. To adjust the URP value,the user uses the up and down arrows to manipulate a horizontal linewhich indicates the URP value that appears on the screen (870). When theghost line is at the desired value, the user presses enter (872).

Once the final URP value is displayed, a Save/Delete screen 874 isoverlayed on the screen. If the user selects the “Save” option, the testresults are saved in memory. If the user selects “Delete” from theSave/Delete screen 874, the user is then presented with the Save Testscreen 876. If “Delete” is chosen the test is deleted, but if “Cancel”is selected, the user is returned to the Save/Delete screen.

According to one embodiment, test results for up to three out of sixpossible tests may be stored. Once three tests have been stored or sixtests have been run, whichever comes first, the control unit 102 willdisable the module identification component 504 via the identificationprobes 502. After testing is complete, the user may return to the mainmenu by selecting the “Menu” option from the Test Complete screen.

One option available from the Main Menu, as stated above, it “Patients,”which allows the user to access patient and test data previously stored.According to one embodiment illustrated in FIG. 8 h, when “Patients” isselected from the Main Menu, a Patients Screen 891 appears. On thisscreen, options for each patient and test for which data has been stored892 are presented and selection of one of these options causes a PatientTest Menu 893 to be displayed (FIG. 8 i). Selecting “Delete” 896 willpresent the user with the option to delete the stored data for thatpatient/test, and selecting “Print” 895 will enable the user to printthe stored data. The Print option will only be available (will not begreyed out) when the control device is coupled to a cradle, or otherwiseappropriately coupled to a printer. Selecting “View Test” will cause aPatients Test screen 898 or 899 to appear depending on whether storeddata is a CMG (898) or a SUI (899) data set. The Patients Test screenmay vary depending on the test module that is attached. For example, forthe SUI stored data, the Patients Test screen is the screen illustratedby 899, whereas for the CMG data (discussed below), the Patients Testscreen is the screen illustrated by 898. The Patients Test screensprovide the user with the option to view data relevant to the particularform of test performed.

As indicated above, the results obtained from the SUI test is theurethral resistance pressure (URP), which is the back-pressure necessaryto force open the urethral sphincter muscle 1306 from the reverse oropposite direction from which fluid normally flows. A major advantage ofthe SUI testing module 1000 is that the insert or plug element 1108 ofthe meatus plug device 1102 only enters the external urethral canal(meatus) and does not cause any discomfort associated with passing acatheter through the internal urethral sphincter. Thus, the diagnosticsystem disclosed herein having a SUI module 1000 is less invasive andmore comfortable for patients. Further, the testing procedure for theSUI module 1000 is easy to implement, quick to perform, and does notrequire advance training by the clinician and/or physician.

SIMPLE CYSTOMETROGRAM (CMG)

The diagnostic system disclosed herein can also be used to perform bothsimple and complex cystometrograms. FIGS. 14–19 show both simple (SCMG)and complex cystometry (CCMG) systems for the testing of bladderfunction in which pressure and volume of fluid in the bladder cavity1308 is measured during filling, storage and voiding. Urologiststypically measure the static pressure relationship in the bladder ofpatients, this being termed as a cystometrogram (CMG), in order todetermine the capacitance of the bladder as a function of pressure andvolume.

Referring now to FIG. 14, the SCMG testing module 1400 includes a modulehousing 1020 b that can be removably coupled to the control device 102in the manner described above. The module housing 1020 b may be in theform of a plastic disposable cartridge. The SCMG testing module containsmany elements that are similar to those described above in connectionwith the SUI testing module, and thus like numerals will be used forthese elements. Contained within the module housing is tubing assembly1004 b including a first fluid conduit 1402 between fluid inlet 1404 andfluid outlet 1406. The tubing assembly also includes a second conduit1408 between a distal end 1410 and a proximal end 1412. Coupled to theproximal end is a filter 1022 b and pressure interface 1412 thatcontacts pressure transducer 128 to convey pressure information theretowhen the SCMG testing module is coupled to the control device. Complianttubing loop 1012 similarly forms part of the first fluid conduit, andcouples with the pump device 118 in the same manner as described abovein connection with the SUI module. The distal ends 1406, 1410 of thefirst and second conduits are each coupled to respective proximal ends1414, 1416 of first and second tubing elements 1418, 1420 of a duallumen catheter 1422 so that the first and second conduits 1402, 1408between the proximal 1414, 1416, and distal 1460, 1462 end of the duallumen catheter are in fluid communication with channels in the first andsecond tubing elements 1418, 1420 of the dual lumen catheter 1422. Thisattachment may be accomplished by an adhesive bond, a solvent bond, anultrasonic weld, or any other suitable type of attachment that creates afluid tight seal. In another embodiment, the dual lumen catheter is aninflatable balloon catheter such as a Foley-type catheter, that includesa pressure sensor 1424 positioned at the tip of the catheter (see FIG.16). Any other suitable catheter may also be used, such as fiber opticor air charged catheters. The pressure sensor may be a micro tiptransducer, an air charged sensor, a fluid charged sensor, a fiber opticsensor or any other pressure measuring sensor.

Use of the diagnostic system to perform a SCMG will now be described indetail with reference to FIGS. 15, 16 and 21. First, the SCMG testingmodule is coupled to the control device in the manner described above(2110). The physical connection causes the identification probes 502 ofthe control unit to engage the module identification element(s) 504 ofthe SCMG testing module, enabling the control device to identify theSCMG testing module in the manner described above. The physical couplingalso brings the pressure interface 1024 b in contact with the pressuretransducer 128 so that pressure changes in the second fluid conduit canbe detected by the pressure transducer. This coupling also causes thetubing loop 1012 to engage the pump device so that the pump can drivefluid through the tubing loop by peristaltic motion, as is alsodescribed above.

Once the SCMG testing module 1400 is coupled to the control device 102,the operator enters input data appropriate for the SCMG test (2115).This data is received and interpreted by the microprocessor 710 andapplicable information is sent by the microprocessor to the display 110.Priming operations are then performed (2120). At this point, themicroprocessor is ready to start the test routine.

The dual lumen catheter 1422 is then inserted into the bladder 1308(2125) via the urethra 1304 and the test is started by pressing theinput pendant switches 124 (2130). The microprocessor 710 receives thesignal from the input pendant switches. Instructions are then sent tothe pump device 118 via the integrated circuit 702. The pump device thenpumps fluid through the first fluid conduit 1402 and tubing element 1418into the bladder (2135). As fluid volume builds in the bladder, pressurein the bladder also builds. This pressure is transmitted through tubingmember 1420 and the second conduit 1408, filter component 1022 b, andpressure interface 1024 b. The pressure transducer 128 receives thepressure data and transcribes it into an electrical signal. Theelectrical signal from the pressure transducer 128 is sent to themicroprocessor 710 via the integrated circuit board 702 where it isacquired and conditioned. During the course of a typical SCMG test, thepatient provides event input, such as feeling the need to void and/orthe intensity of that feeling, which is input to the control device viainput pendant switches 124, as will be described more fully below. Themicroprocessor ends the test (2140) after a specified amount of time, orupon receipt of an “off” signal from input pendant switch 124. Once thetest has been completed, the operator and removes the catheter 1422 fromthe bladder (2145). Following the test the software then exits the SCMGtest subroutine, and the data storage routine is run to store and/ordisplay results of the test.

Referring again to FIGS. 8 a–i, and in particular FIG. 8 e, when the“Test” option is selected the SCMG test can be performed. The SCMG Testscreen appears 870 a, and the user initiates the test by depressinginput pendant switch 124 (see FIG. 10 a) quickly. The pump device isthen activated and pumping begins 872 a. In a preferred embodiment,fluid is infused into the patient's bladder at a rate of approximately 1ml/sec. As such, this test may be approximately 16 minutes in duration,as opposed to approximately 15–20 seconds that may be required for theSUI test.

As the bladder is filling, the patient communicates the point in time atwhich he/she feels the initial sensation of needing to void, and theuser presses the input pendant switch 124 to mark this point in time 873a. The fluid infusion continues, and the user then marks the point intime at which the patient feels the urge to void 874 a, and the point atwhich the patient feels an extreme, almost unbearable urge to void 875a, or has voided. Upon this third marking, the fluid infusion ceases andthe test is completed 876 a. During fluid infusion and after the test iscomplete, a graph is displayed illustrating pressure versus volumeinfused. After completion of the test a Save/Delete overlay 877 appears.Selecting “Save” and pressing enter saves the test data. Selecting“Delete” causes a Save/Delete screen 878 overlay to appear. Selecting“Delete” from this screen deletes the data, where as selecting “Cancel”from this screen returns to the Save/Delete overlay.

At any point between initiating pumping and completing the SCMG test,the user may pause the test by depressing and holding, or pressingfirmly on the input pendant switch 880, which causes the pump device tostop pumping fluid into the patient's bladder, and a Pause screen 881(FIG. 8 f) to appear on the display. Selecting “Quit” causes a End Testscreen 885 to appear, and if “OK” is selected the test is stopped 886.If “Cancel” is selected the Pause screen reappears. If “Resume” 883 isselected from the Pause screen 881, the SCMG test resumes where it leftoff (pumping begins again). If, however, “LPP” 882 is selected from thePause screen 881, assessment of the patient's leak point pressure (LPP)begins. No pumping of fluid occurs during this test. First, a LPP screen887 appears and a blank graph is displayed. Pressure in centimeters ofwater is plotted on the vertical axis versus time on the horizontalaxis. The patient then proceeds to exert pressure on the bladder as ifattempting to void 888. The user marks the point at which a leak occurs889, and the test is automatically completed after three minutes orthree leaks, upon which the user is returned to the Pause screen 881.LPP results may then be stored or deleted, the CMG test may be resumed,or the test can be terminated altogether.

COMPLEX CYSTOMETROGRAM

In reference to FIGS. 17–19, the complex CMG (CCMG) testing module 1700is similar to the SCMG testing module, but the tubing assembly alsoincludes an additional single lumen tubing member 1702 having a proximalend 1704 and a distal end 1706 and a third conduit extendingtherethrough. The proximal end 1704 of the single lumen tubing member iscoupled to another filter component 1022 c and pressure interface 1024c. Pressure interface 1024 c contacts pressure transducer 1030 when theCCMG testing module is coupled to the control device, enabling pressuretransducer 1030 to sense pressure within the third fluid conduit.

Use of the diagnostic system to perform a CCMG will now be described indetail with reference to FIGS. 18, 19 and 22. First, the CCMG module iscoupled to the control device (2210). The physical connection causes theidentification probes 502 of the control device 102 to engage theidentification elements 504 of the CCMG testing module, enabling thecontrol device to identify the CCMG testing module. The physicalcoupling also brings pressure interfaces 1024 b, 1024 c in contact withthe pressure transducers 128, 1030 so that pressure changes in thesecond and third conduits can be detected by the pressure transducers.This coupling also causes the tubing loop 1012 to engage the pump device118 so that the pump can drive fluid through the tubing in the CCMGmodule.

Once the CCMG testing module 1700 is coupled to the control device 102,the operator enters input data appropriate for the CCMG test (2215).This data is received and interpreted by the microprocessor 710 andapplicable information is sent by the microprocessor to the display 110.Priming operations are then performed (2220

The dual lumen catheter 1422 is inserted into the bladder via theurethra 1302 (2225). The single lumen catheter 1702 is inserted intoeither the vagina or the rectum (2230) and the test is started (2235) bypressing the input pendant switches 124. The microprocessor 710 receivesthe signal from the input pendant switches. This in turn sendsinstructions to the pump device 118 via the integrated circuit 702, andthe pump device pumps fluid through the first tubing conduit 1042 andtubing element 1418 into the bladder (2240). As fluid volume builds inthe bladder, pressure in the bladder also builds. This pressure istransmitted through pressure interface 1024 b to pressure transducer128. Similarly, abdominal pressure is transmitted through pressureinterface 1024 c to pressure transducer 1030. The pressure transducersreceive the pressure data and transcribe it into electrical signals. Theelectrical signals are sent to the microprocessor 710 via the integratedcircuit board 702 where it is acquired and conditioned. Themicroprocessor ends the test after a specified amount of time or uponreceipt of an “off” signal from input pendant switches 124 (2245). Oncethe test has been completed, the operator disengages the input pendantswitches and removes the catheters 1422 and 1702 from the bladder(2250). The stored information is then available for review on thedisplay screen, or by a print out through a charging cradle (printerassembly), or downloaded to a PC via a software interface in thecharging cradle.

Referring again to FIGS. 8 a–i, the CCMG module software subroutine andgraphical user interface is substantially as described in connectionwith the SCMG module. The system subtracts the abdominal pressure fromthe bladder pressure to calculate detrusor (bladder muscle) pressure.Detrusor pressure is then plotted against volume.

Both the SCMG and CCMG testing modules 1400 and 1700 provide a simple,relatively low cost procedure for recording a cystometrogram (CMG). TheSCMG and CCMG testing modules are sterile, disposable assemblies thateliminate the need to disinfect equipment prior to use. This, togetherwith a relatively simple set-up and operational procedure by thephysician, greatly reduces the time required to obtain the urodynamicdata. The SCMG and CCMG testing modules are more comfortable for thefemale patient and are more cost effective for the physician. Thesimplicity of the SCMG and CCMG testing modules, and the control device102 allows operation with minimal training. Further, when combined inoperational use with the SUI testing module 1000, these modules providea near complete urodynamic diagnostic tool for the physician.

UROFLOMETRY

A uroflometry testing module 2400 can also be removably coupled tocontrol device 102. The module housing of the uroflometry testing module2400 may be in the form of a plastic disposable cartridge. As shown inFIGS. 24 and 25, the Uroflometry testing module 2400 includes a singlelumen tubing member 2402 having a proximal end 2404 and a distal end2406 and a channel extending substantially therethrough. A balloon 2408or other suitable elastomeric element is coupled to the distal end 2406,however, so that the channel of the single lumen tubing member is notopen at the distal end. A pressure cushion may also be used in place ofthe balloon. A collection bucket 2410 is positioned on top of theballoon. The inner surface of the collection bucket may also contain aurinalysis strip which, when wetted by the voided urine, allows forquantitative assessment of standard urinalysis parameters

The diagnostic system including the Uroflometry testing module isoperated as follows. The collection bucket is positioned under a commode2412 to collect urine as the patient voids. Balloon is positionedrelative to the bucket so that it substantially supports the bucket. Asthe bucket fills the pressure in the balloon rises proportionately tothe weight of the fluid. When the testing module is coupled to thecontrol device, the proximal end 2404 of the single lumen tubing member2402 contacts the pressure transducer 128 of the control device 102 sothat the pressure within the balloon can be captured and interpreted bythe control device. The pressure data is used to calculate the weightand volume of the fluid (known fluid density). The stored information isthen available for review on the display screen, or by a printoutthrough a charging cradle (printer assembly), or downloaded to a PC viaa software interface in the charging cradle. Once the test has beencompleted, the operator disengages the input pendant switches 124, andthe urine and collection bucket are discarded.

Operation of the Uroflometry module software subroutine is illustratedin FIGS. 8 a–b. Following module detection 802 and a command to executethe UroFlow Module Subroutine 804, the UroFlow module subroutine begins.The operator is prompted to Enter UroFlow Patient Data 840 necessary forthe UroFlow test routine. Once the patient data is collected a UroFlowScale Zeroing Procedure 841 runs. The operator then enters informationnecessary to initiate the UroFlow test (UroFlow Test I/O) and the testis started 842. Following the test the software then exits the UroFlowtest subroutine and stores the data collected in the Data Storageroutine.

VAGINAL SPECULUM

FIGS. 26–28 illustrate a vaginal speculum assembly 2600 for use in thereduction of vaginal prolapse when performing female urodynamic testing,as previously discussed. Uterine or vaginal prolapse occurs when theuterus or pelvic organs drop or become displaced because of weakenedpelvic muscles. Prolapse must be reduced to effectively performurodynamic tests to ensure that no underlying stress urinaryincontinence symptoms are masked by the pressure of the vaginalprolapse, which may cause distortion or kinking of the urethral canal.The vaginal speculum assembly 2600 will permit the clinician orphysician to perform a urodynamic test procedure with one hand whilestill reducing vaginal prolapse, as well as properly position the meatusplug device or other catheter within the urethral canal. This prolapsemaneuver using the vaginal speculum assembly 2600 during urodynamictesting is especially important prior to surgical repair of the vaginalprolapse, as an undiagnosed case of stress urinary incontinence maysurface following prolapse surgery. The urodynamic testing beingperformed using the vaginal speculum assembly in this manner allows thesurgeon to determine if additional stress urinary incontinence (SUI)surgery should be performed at the time of prolapse repair.

Current medical practice calls for the use of a vaginal speculum securedin place in order to reduce the prolapse. For example, U.S. Pat. Nos.5,997,474 and 6,048,308 describe specula specifically designed forvaginal examination and treatment. U.S. Pat. No. 6,120,438 discloses avaginal retractor device designed to hold back the vaginal wall duringan exam or surgical procedure. Often, surgical tape is necessary to holdthe speculum in place, as the physician's hands cannot hold the speculumin place while performing a particular urodynamic procedure. None of theprior art speculum devices integrate the use of urodynamic equipment.

With reference to FIGS. 26 and 27, the vaginal speculum assembly 2600includes a connector member 2602 for coupling an insertion deviceassembly, such as a meatus plug device 1102, or catheter 1422 andrelated elements to the vaginal speculum. The vaginal speculum can be ofany type well known in the art. In the illustrated embodiment, thevaginal speculum includes an upper arm 2604, a lower arm 2606, and ahinge member 2608 for joining the upper and lower arms together. Thevaginal speculum also includes a handled member 2610 being integrallyattached, and preferably substantially perpendicular aligned to thelower arm. The vaginal speculum 2600 further includes a locking bardevice 2612 connected to the upper arm 2606 for locking the upper andlower arms in an open position, as shown in FIG. 28. The upper arm 2604includes a posterior end 2614 with a pair of arm mounting openings 2616therein. The connector member 2602 includes a flexible band 2618. Theflexible band at one end 2620 includes a pair of mounting openings 2622and at the other end 2624 a connector element 2626. The mountingopenings 2622 of the flexible band 2618 are aligned with the armmounting openings 2616 of the upper arm for receiving a pair of mountingscrews 2628 therein in order to attach the connector member 2602 to thevaginal speculum 2600. During use, the connector element can be coupledto the meatus plug device or catheter as shown in FIG. 26.

Although a particular embodiment of the connector member 2602 isillustrated and described herein, those skilled in the art willrecognize that various other embodiments are also possible to provide ameans by which to removably couple a device that is inserted into theurethral canal to the speculum so as to hold it in place within thepatient.

In operation, the vaginal speculum assembly 2600 can be cooperativelyused in conjunction with the urodynamic system disclosed herein. Forexample, it may be used in conjunction with a urodynamic systemincluding a SUI testing module 1000 in the performance of the urodynamictesting procedure for stress urinary incontinence (SUI), such as themeasuring of urethral resistance pressure (URP) as previously described.In reference to FIG. 28, the physician positions the vaginal speculumassembly 2600, such that it is fully inserted within vaginal canal 2650wherein the upper and lower arms 2604, 2606 are fully opened and pressedagainst the vaginal walls 2650 w for reducing the patient's vaginalprolapse. The physical then locks the upper and lower arms of thevaginal speculum in the fully opened configuration (see FIG. 28) via thelocking bar device 2612, and adjusts the connector member 2602 so thatthe insert member will be aligned with the urethral canal. The remainingoperational steps are exactly the same as the operational stepsdescribed above in connection with individual testing modules.

Although the portable medical system disclosed herein has been describedin conjunction with diagnostic testing, it is to be understood that thesystem can also be used in conjunction with therapies and/or surgicalprocedures for treating urinary incontinence, such as placement of asling, placement of bulking agents, shrinkage of tissue etc. In thisregard, the testing described herein can be used before, during and/orafter these procedures to ensure success of the procedures, for example,to ensure correct placement and/or tensioning of a sling.

Although exemplary embodiments and methods for use have been describedin detail above, those skilled in the art will understand that manyvariations are possible without departing from the spirit and scope ofthe invention, which is limited only by the appended claims.

1. A portable, self-contained medical diagnostic system for assessingurinary function comprising: a control device having a substantiallyrigid outer casing, and including a microprocessor, a pump device,memory storing therein at least one software routine, and a pressuresensor are positioned within the outer casing; a test module having asubstantially rigid outer casing, the test module being removablycoupled to the control device, and further comprising a pressureinterface positioned within the test module outer casing and a tubingassembly positioned partially within the test module housing anddefining a first fluid conduit between a first fluid inlet and a firstfluid outlet, wherein the pump device is coupled with the first fluidconduit for pumping fluid therethrough; and an insert member having afirst channel therethrough and coupled to the first fluid outlet so thatfluid flowing through the first fluid conduit may flow through the firstchannel, the insert member being dimensioned for insertion into apatient's bladder through the patient's urethral canal, wherein, whenthe insert member is inserted into the patient's bladder, the pressureinterface is in fluid communication with the bladder such that apressure at the pressure interface substantially corresponds to apressure within the bladder, the pressure interface further beingpositioned relative to the pressure sensor so as to transmit bladderpressure information thereto, and wherein the microprocessor, viaexecution of the at least one software routine, controls operation ofthe pump and obtains bladder pressure information.
 2. The diagnosticsystem according to claim 1, wherein the pump device is electricallycoupled to and controlled by the processor, and wherein the pressuresensor is electrically coupled to and provides bladder pressureinformation to the processor.
 3. The diagnostic system according toclaim 1, wherein the test module further comprises a moduleidentification device coupled with a module detection device in thecontrol device, wherein the module detection device is electricallycoupled to the control device processor.
 4. The diagnostic systemaccording to claim 1, wherein the insert member is a catheter.
 5. Thediagnostic system according to claim 4, wherein the catheter is a duallumen catheter further comprising a second channel therethrough, whereinthe pressure interface is in fluid communication with the secondchannel.
 6. The diagnostic system according to claim 1, wherein the testmodule further comprises a test module housing having at least one tabelement projecting therefrom for engaging the control device, and afirst port therein dimensioned to receive the control device pressuresensor, wherein the pressure interface is positioned within the firstport.
 7. The diagnostic system according to claim 1, wherein the testmodule further comprises a second tubing conduit having an opening atone end thereof, and a second pressure interface in fluid communicationwith the second tubing conduit.
 8. The diagnostic system according toclaim 7, further comprising a second insert member coupled to the secondtubing conduit opening, and dimensioned for insertion into the patient'sbody at a second location other than the urethral canal from whichabdominal pressure can be sensed, the second insert member having achannel therethrough and being coupled to the second tubing conduit suchthat a pressure at the second interface substantially correlates to apressure at the second location.
 9. A medical diagnostic systemcomprising: a control device including a microprocessor and pump deviceelectrically coupled to and controlled by the processor; a test moduleremovably coupled to the control device and including a tubing assemblyhaving a first fluid inlet, a first fluid outlet, and a first fluidconduit extending therebetween; an insert member coupled to the tubingassembly fluid outlet and having a channel therethrough in fluidcommunication with the first fluid conduit, the insert member beingdimensioned for insertion into a patient's bladder through the patient'surethral canal; a pressure detection system for detecting pressurecorrelating to a pressure within the bladder; wherein the pump device iscoupled to the first fluid conduit to, under control of themicroprocessor, pump fluid through the first fluid conduit and insertmember channel and into the bladder, and wherein the pressure detectionsystem detects pressure within the bladder as fluid is pumped thereinand provides data correlating to the detected pressure to themicroprocessor.
 10. The diagnostic system according to claim 9, whereinthe insert member is a dual lumen catheter further comprising a secondchannel therethrough having an open distal end in proximity with an opendistal end of the first channel, and wherein the pressure detectionsystem further comprises a pressure interface within the test module influid communication with the second fluid conduit.
 11. The diagnosticsystem according to claim 9, wherein the test module further comprises amodule identification device coupled with a module detection device inthe control device, wherein the module detection device is electricallycoupled with the control device processor.
 12. The diagnostic systemaccording to claim 9, wherein the test module further comprises apressure interface in fluid communication with the bladder when theinsert member is inserted into the patient's bladder, and a test modulehousing having at least one tab element projecting therefrom forengaging the control device, and a first port therein dimensioned toreceive the control device pressure sensor, wherein the pressureinterface being positioned within the first port.
 13. The diagnosticsystem according to claim 9, wherein the test module further comprises asecond tubing conduit having an opening at one end thereof, and a secondpressure interface in fluid communication with the second tubingconduit.
 14. The diagnostic system according to claim 13, furthercomprising a second insert member coupled to the second tubing conduitopening, and dimensioned for insertion into the patient's body at asecond location other than the urethral canal from which abdominalpressure can be sensed, the second insert member having a channeltherethrough and being coupled to the second tubing conduit such that,when the second insert member is inserted into the patient's body, apressure at the second interface substantially correlates to a pressureat the second location.
 15. A method for assessing urinary functioncomprising the steps of: removably coupling a test module to a controldevice to form a portable, self-contained diagnostic system, the controldevice including a microprocessor, a pump device and a pressure sensor,wherein operation of the pump device is controlled by the microprocessorand data correlating to pressure sensed by the pressure sensor isprovided to the microprocessor, and the testing module including a fluidtubing assembly having a first fluid inlet, a first fluid outlet and afirst fluid conduit extending therebetween; coupling to the first fluidoutlet an insert member having a channel therethrough in fluidcommunication with the first fluid conduit; coupling the first fluidinlet to a fluid source; inserting the insert member into a patient'sbladder through the patient's urethral canal; causing the microprocessorto execute the at least one software routine to thereby cause activationof the pump device to thereby infuse fluid from the fluid source throughthe first fluid conduit and insert member channel and into the bladder;and measuring pressure within the bladder as fluid is infused therein.16. The method according to claim 15, wherein the step of removablycoupling the test module to the control device further comprisescoupling a pressure interface in the test module with a pressure sensorin the control device that is electrically coupled to the processor. 17.The method according to claim 16, wherein the step of removably couplingthe test module to the control device further comprises coupling thepump device with the first fluid conduit.
 18. The method according toclaim 15, wherein the test module further comprises a second fluidconduit having a distal open end and a second pressure interface influid communication with the second fluid conduit, the method furthercomprising coupling a second insert member to the distal open end andinserting the second insert member into the patient's body at a secondlocation other than the urethral canal from which abdominal pressure canbe sensed, the second insert member having a channel therethrough andbeing coupled to the second tubing conduit such that, when the secondinsert member is inserted into the patient's body, a pressure at thesecond interface substantially correlates to a pressure at the secondlocation.
 19. A self-contained medical diagnostic system for assessingurinary function comprising: a control device including amicroprocessor, a pump device electrically coupled to and controlled bythe processor, and a first pressure sensor; a testing module removablycoupled to the control device, the testing module further comprising afirst fluid conduit extending between a first fluid inlet and a firstfluid outlet, and a second conduit having a first open end and a firstpressure interface in fluid communication therewith; and a first insertmember having first and second channels therethrough, the first channelbeing in fluid communication with the first fluid conduit and the secondchannel being in communication with the second conduit, the insertmember being dimensioned for insertion into a patient's bladder throughthe patient's urethral canal, wherein the pump device is coupled to thefirst fluid conduit for infusing fluid through the first fluid conduit,the first insert member channel and into the bladder, and wherein thefirst pressure interface and first pressure sensor are positionedrelative to one another so that the first pressure interface transmitspressure information to the first pressure sensor.
 20. The diagnosticsystem according to claim 19, wherein the control device furthercomprises a second pressure sensor, and the test module furthercomprises a third tubing conduit having a first open end and a secondpressure interface in communication therewith.
 21. The diagnostic systemaccording to claim 20, further comprising a second insert member coupledto the first open end of the third tubing conduit and being dimensionedfor insertion into the patient's body at a second location other thanthe urethral canal at which abdominal pressure can be sensed.
 22. Thediagnostic system according to claim 21, wherein the second location isthe rectum.
 23. The diagnostic system according to claim 21, wherein thesecond location is the vaginal canal.